None
Conditions
Interventions
Trade Name: Daxas
Product Name: Daxas
Product Code: 162401-32-3
Pharmaceutical Form: Tablet
INN or Proposed INN: ROFLUMILAST
CAS Number: 162401-32-3
Other descriptive name: Daxas
Concentration unit:
Sponsors
Maastricht University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 18 to 35 years of age • Healthy (i.e. absence of all exclusion criteria), normal static binocular acuity (corrected or uncorrected), • Body mass index between 18.5 and 30 • Willingness to sign an informed consent. • Positive evaluation on the memory screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Volunteers who suffer from, or have a history of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological, or psychiatric illness, will be excluded. Those volunteers who have a first-degree relative with a psychiatric disorder or a history of depressive disorder with or without suicidal risk will be excluded as well. Other exclusion criteria are excessive drinking (>20 glasses of alcohol containing beverages a week), pregnancy or lactation, use of chronic medication other than oral contraceptives, use of recreational drugs from 2 weeks before until the end of the experiment, smoking, orthostatic hypotension, lactose intolerance, and any sensory or motor deficits which could reasonably be expected to affect test performance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate whether roflumilast improves declarative episodic memory. Memory function will be assessed using the verbal learning task (VLT), which assesses short- and long-term memory, using word lists. This task is particularly relevant since it assesses declarative episodic memory, a function primarily involving the hippocampus. Considering the evidence of high PDE-4 expression in this specific structure, we expect a larger effect size for cognitive functions related to this brain area.;Secondary Objective: Our second objective is twofold. Other types of cognition will be measured using the Stroop task, continuous performance task (CPT) and the spatial memory task (SMT). The first two tasks measure response inhibition and focused attention, the latter task measures spatial memory. In addition, EEG recordings are included to gain insight in the electrophysiological correlates of cognition. A sensory gating paradigm is included which enables us to examine the effect of our treatment on specific ERP components related to basic auditory processing;Primary end point(s): Main study parameters are the scores on the memory tasks. The verbal learning task the object relocation task, and the spatial memory task are selected for this purpose. Secondary, the continuous performance test and the stroop task will be included to assess attention and response inhibition. ;Timepoint(s) of evaluation of this end point: Data will be analysed after all 20 subjects have been tested. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Event-related potentials inferred from the EEG signal during those tasks will be analysed. In addition, auditory evoked potentials will give an indication of the role of roflumilast in information processing. Finally, the ratio (S2/S1) of the P50 will be included as a measure of sensory gating.;Timepoint(s) of evaluation of this end point: Data will be analysed after all 20 subjects have been tested. | — |
Countries
Netherlands
Contacts
Public ContactM. van Duinen
MUMC+
Outcome results
None listed